Quick answers
- What is Pitavastatin used for?
- The FDA-approved label (Livalo, Kowa Pharmaceuticals America, Inc., March 31, 2026) says: “LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). LIVALO is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pitavastatin have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pitavastatin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pitavastatin been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started February 3, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Pitavastatin?
- 14 companies list prescription products of Pitavastatin in the FDA NDC Directory, including Zydus Lifesciences Limited, Golden State Medical Supply, Inc. and Zydus Pharmaceuticals USA Inc..
What Pitavastatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). LIVALO is a HMG-CoA reductase inhibitor (statin) indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. …
— FDA label: Livalo, Kowa Pharmaceuticals America, Inc., effective March 31, 2026. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| pitavastatin calcium 1 mg tablet | Generic | $0.8365 per tablet |
| pitavastatin calcium 1 mg tablet, film coated | Generic | $0.8365 per tablet |
| pitavastatin calcium 1.045 mg tablet, film coated | Generic | $0.8365 per tablet |
| pitavastatin calcium 1.045 mg tablet, film coated | Brand: Livalo | $10.19 per tablet |
| pitavastatin calcium 2 mg tablet | Generic | $0.9690 per tablet |
| pitavastatin calcium 2 mg tablet, film coated | Generic | $0.9690 per tablet |
| pitavastatin calcium 2.09 mg tablet, film coated | Generic | $0.9690 per tablet |
| pitavastatin calcium 2.09 mg tablet, film coated | Brand: Livalo | $10.20 per tablet |
| pitavastatin calcium 4 mg tablet | Generic | $0.9889 per tablet |
| pitavastatin calcium 4 mg tablet, film coated | Generic | $0.9889 per tablet |
| pitavastatin calcium 4.18 mg tablet, film coated | Generic | $0.9889 per tablet |
| pitavastatin calcium 4.18 mg tablet, film coated | Brand: Livalo | $10.22 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Zydus Lifesciences Limited5 products
- Golden State Medical Supply, Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Teva Pharmaceuticals, Inc.3 products
- Camber Pharmaceuticals, Inc.3 products
- Kowa Pharmaceuticals America, Inc.3 products
- AvKARE3 products
- Amneal Pharmaceuticals LLC3 products
- Mylan Pharmaceuticals Inc.3 products
- XLCare Pharmaceuticals, Inc.3 products
- Aurobindo Pharma Limited3 products
- Upsher-Smith Laboratories, LLC3 products
- NorthStar RxLLC2 products
- Medicure International Inc2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022363 LIVALO | Kowa Co | August 3, 2009 | 14, latest March 14, 2024 2024: Labeling · 2022: Labeling · 2020: Labeling |
| NDA208379 ZYPITAMAG | Medicure | July 14, 2017 | 3, latest January 31, 2024 2024: Labeling · 2020: Labeling · 2020: Labeling |
Generic approvals (7)
- ANDA206015Aurobindo Pharma · December 20, 2016
- ANDA205932Orient Pharma Co Ltd · February 3, 2017
- ANDA205955Sawai USA · February 3, 2017
- ANDA206070Mylan · April 4, 2019
- ANDA206047Zydus Pharms · February 22, 2023
- ANDA205977Hetero Labs Ltd V · April 30, 2024
- ANDA205961Amneal Pharms Ny · August 20, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 3, 2026 · Class III · Ongoing · D-0391-2026
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01. — Annora Pharma Private Limited
-
June 26, 2025 · Class III · Ongoing · D-0529-2025
Failed Impurity/Degradation Specifications
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90 — AvKARE
-
June 26, 2025 · Class III · Ongoing · D-0528-2025
Failed Impurity/Degradation Specifications
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90 — AvKARE
-
June 11, 2025 · Class III · Ongoing · D-0527-2025
Failed Impurities/Degradation Specifications.
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiw — Orient Pharma Co., Ltd. Yunlin Plant
-
June 11, 2025 · Class III · Ongoing · D-0526-2025
Failed Impurities/Degradation Specifications.
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiw — Orient Pharma Co., Ltd. Yunlin Plant
-
February 24, 2025 · Class III · Completed · D-0258-2025
Presence of foreign tablets/capsules
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuti — Kowa Pharmaceuticals America
-
March 15, 2021 · Class II · Terminated · D-0500-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Livalo, Kowa Pharmaceuticals America, Inc., effective March 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →